E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acutely ill hospitalised children who need intravenous fluid therapy. |
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E.1.1.1 | Medical condition in easily understood language |
Children who need intravenous fluid therapy. |
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E.1.1.2 | Therapeutic area | Body processes [G] - Physiological processes [G07] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main objective of the trial is to evaluate the risk of hypokalemia (low plasma potassium concentration) following administration of a Plasmalyte Glucos 50 mg/mL solution compared to a glucose 5% solution containing potassium chloride 20 mmol/L and sodium chloride 80 mmol/L. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective of the trial is to evaluate the risk of hyponatremia (low plasma sodium concentration) following administration of a Plasmalyte Glucos 50 mg/mL solution compared to a glucose 5% solution containing potassium chloride 20 mmol/L and sodium chloride 80 mmol/L. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Acutely ill hospitalised children aged between 6 months and 12 years that need intravenous fluid therapy. |
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E.4 | Principal exclusion criteria |
An initial plasma sodium concentration of lower than 130 mmol/L or higher than 150 mmol/L; an initial plasma potassium concentration of lower than 3.0 mmol/L; need for 10% glucose solution; diabetes, diabetes insipidus or diabetic ketoacidosis; renal disease that needs dialysis; protocol-determined chemotherapy hydration; severe liver disease; inborn errors of metabolism that need protocol-determined fluid therapy. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Incidence of hypokalemia (plasma potassium concentration of lower than 3.5 mmol/L). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Daily during the intravenous fluid therapy. |
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E.5.2 | Secondary end point(s) |
Incidence of hyponatremia (plasma sodium concentration of lower than 132 mmol/L); incidence of hypernatremia (plasma sodium concentration of higher than 148 mmol/L); change in weight; change of intravenous fluid regimen; amounts of extra sodium and potassium added to solutions; duration of intravenous fluid therapy. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Daily during the intravenous fluid therapy. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Glucose 5% solution containing sodium chloride 80 mmol/L and potassium chloride 20 mmol/L. |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |